Kornimate/medical-research-clean huggingface dataset:
contribution of optical coherence tomography in the endovascular treatment of femoral occlusions

Conditions: Superficial Femoral Artery Stenosis; Claudication; Ischemic Leg

Summary: this is a common care study. a study for evaluating the quality of balloon inflation and stent application will be performed in 2d angiography alone in the control group and then by 2d and oct angiography for the experimental group. the benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to oct which allows a 3d visualization of the arterial lumen.


Eligibility criteria:
inclusion criteria: * patient over 18 years old * femoral-popliteal lesion tasc-c or tasc-d de novo (f1 to p1) * starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (p2) * ≥1 continuous permeable leg axis directly injecting the plantar arch * rutherford 2-5 exclusion criteria: * patient under personal protection regime (tutorship, guardianship) * absence of arterial axis in permeable leg * patient presenting a limb acute ischaemia (chart evolving since less than 14 days) * patient without favorable element to consider healing * history of stents on the femoropopliteal axis * history of femoropopliteal bypass * untreated stenosis ≥30% on the iliac axis and common femoral upstream * popliteal lesion beyond the intercondylar notch (p2)

Keywords: femoral recanalization optical coherence tomography (oct) endovascular treatment tasc-c, tasc-d
the efficacy and safety study of toripalimab injection combined with chemotherapy for nasophapyngeal cancer

Conditions: Recurrent or Metastatic NPC

Summary: this is a randomized, placebo-controlled, multi-center, double blinded, phase iii study to determine the efficacy and safety of toripalimab injectio（js001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic npc. the primary endpoint is pfs in all patients. approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of js001 (arm a) or placebo (arm b) with gemcitabine and cisplatin given every 3 weeks (q3w) in 3-week cycles.

total 289 patients were enrolled and randomized in a 1:1 ratio to the group of js001 (arm a) with gemcitabine and cisplatin or placebo (arm b) with gemcitabine and cisplatin every 3 weeks (q3w) in the 'during chemotherapy' phase. during the 'post-chemotherapy' phase, patients randomized to arm a or arm b will continue treatment with js001 or placebo as maintenance therapy q3w until excessive toxicity or progressive disease, withdrawal of consent or investigator's judgement or a maximum of 2 years. tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. the primary objective is to compare pfs as assessed by the irc in itt population (all randomized patients).

Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years and ≤75 years. * 2. histological/cytological confirmation of npc. * 3. primarily metastatic (stage ivb as defined by the international union against cancer and american joint committee on cancer staging system for npc, eighth edition) or recurrent npc that is not amenable for local regional treatment or curative treatment. * 4. at least 1 measurable lesion according to recist version 1.1. * 5. life expectancy ≥ 3 months exclusion criteria: * 1. history of severe hypersensitivity reactions to other mabs or any ingredient of js001. * 2. prior therapy targeting pd-1 receptor, or its ligand pd-l1, or cytotoxic t lymphocyte associated protein 4 (ctla4) receptor. * 3. major surgical procedure other than for diagnosis of npc within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study * 4. history of hypersensitivity to gemcitabine or cisplatin or to any of the excipients. * 5. female patients who are at pregnancy or lactation.
is drainage necessary after total hip replacement?

Conditions: Osteoarthritis, Hip

Summary: the goal of this study was to compare early results of total hip replacement (thr) in 2 groups of patients: with and without closed suction drainage (csd). patients were followed for 3 months post operatively.

after approval from the local ethical committee, patients undergoing total hip replacement (thr) were included in this study. patients with previous hip surgeries and coagulation disorders were not included. all patients were submitted to a non-cemented total hip replacement (thr) through a hardinge's approach. before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (csd) and group 2 - without closed suction drainage (csd). in the group 1, a sub-fascial suction drain was used, and kept for 24 hours. data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers c-reactive protein (crp), erythrocyte sedimentation rate (esr) and leucogram, harris hip score (hhs) after 3 months, and complications. patients were followed for 3 months post operatively.

Eligibility criteria:
inclusion criteria: * primary hip arthroplasty * lateral hardinge approach * non-cemented acetabular and femoral components * length of skin incision between 10 and 20 cm exclusion criteria: * coagulative disorders * previous surgery in the same limb * age below 18 years old

Keywords: suction arthroplasty replacement hip
effectiveness of a knee brace when combined with viscosupplementation in the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: hypothesis: viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee oa then treating with viscosupplementation alone

a randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. the viscosupplementation and off-loading knee brace are being used in accordance with their fda approval. subjects will be randomized to 1 of 3 treatment groups. the control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. the second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. the third group will use the off loading knee brace alone. subjects will complete the womac osteoarthritis questionnaire (pain, stiffness, function) and vas pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. subjects in group 2 and 3 will be given a brace diary to record compliance.

Eligibility criteria:
inclusion criteria: * subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs. * radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment. * subjects will also have a documented varus deformity. exclusion criteria: * subjects with severe arthritis as demonstrated by radiographs. * in addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded. * female patients who are pregnant or breast feeding will also be excluded.
a study to evaluate the effect of mk0966 (rofecoxib) on the recurrence of colorectal adenomas (0966-122)

Conditions: Colorectal Adenoma

Summary: this study was to compare the effect of 156 weeks of treatment with mk-0966 (rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the large intestine, also known as the colon) in patients with a history of colorectal adenomas.


Eligibility criteria:
inclusion criteria: * eligible patients must have undergone a complete colonoscopy within 12 weeks of study entry with removal of all polyps; at least one polyp must have been confirmed a large bowel pre-cancerous polyp (adenoma) by the study pathologist. exclusion criteria: * history with a specific hereditary large bowel polyp syndrome * history of a large bowel adenoma before age 35 * small or large bowel resection or history of inflammatory bowel disease * history of cancer within the five years before enrollment * expected need for chronic nsaid therapy * positive test result for stool occult blood * uncontrolled hypertension, stroke or temporary mini stroke (tia) within the past 2 years, angina or congestive heart failure with symptoms that occur at rest or with minimal activity * history of myocardial infarction (heart attack), coronary angioplasty, or coronary artery bypass grafting within the past 1 year * pregnancy
rheumatology patient registry and biorepository

Conditions: Rheumatic Diseases; Adult Onset Still Disease; Ankylosing Spondylitis; Psoriatic Arthritis; Reactive Arthritis; Antiphospholipid Syndrome; Systemic Lupus Erythematosus; Behcet Disease; Dermatomyositis; Polymyositis; Giant Cell Arteritis; Lyme Disease; Mixed Connective Tissue Disease; Polymyalgia Rheumatica; Rheumatoid Arthritis; Sarcoidosis; Systemic Sclerosis; Scleroderma; Sjogren's Syndrome; Undifferentiated Connective Tissue Diseases

Summary: to facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

a rheumatology biorepository will be created to permit comparative analyses between the rheumatic diseases in order to increase the understanding of disease pathogenesis. patients seen at yale clinics diagnosed with rheumatic diseases are invited to participate in this study. these rheumatic diseases include, but are not limited to: adult onset still's disease, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, antiphospholipid syndrome, systemic lupus erythematosus, behcet's disease, dermatomyositis, polymyositis, giant cell arteritis and other vasculitides, lyme's disease, mixed connective tissue disease, polymyalgia rheumatica, rheumatoid arthritis, sarcoidosis, systemic sclerosis (scleroderma), sjogren's syndrome, and undifferentiated connective tissue disease.

Eligibility criteria:
inclusion criteria for rheumatology patients: * patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including, but not limited to: adult onset still's disease, ankylosing spondylitis, antiphospholipid syndrome, behcet's disease, dermatomyositis, giant cell arteritis, mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma, sjogren's syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease and vasculitis. * receiving clinical care at yale rheumatology clinics exclusion criteria for rheumatology patients: * unable to provide informed consent * no patients will be excluded based on gender or ethnicity or pregnancy status. * women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver. * patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy. inclusion criteria for healthy volunteers: * age ≥ 18 years old * no chronic skin conditions * no diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis) * normal bmi exclusion criteria for healthy volunteers: * unable to provide informed consent. * currently pregnant or nursing unless the study goal is to study pregnant or nursing woman. * allergies to lidocaine or epinephrine (skin biopsies). * a history of impaired wound healing (skin biopsies).
mbrain-21 : a three-month study on context-awareness, physiological monitoring, and machine learning in migraine and cluster headache

Conditions: Migraine; Cluster Headache

Summary: this study collects data from migraine and cluster headache patients during a three-month study. contextual data (e.g. location or smartphone usage) and physiological variables will be used to assist machine learning algorithms in making predictions on activity, stress and sleep in patients with migraine or cluster headache.

migraine and cluster headache are brain disorders with disabling headache attacks and assoicated symptoms. attacks have multiple phases such as the premonitory phase, aura phase, headache phase and postdromal phase. during those phases, symptoms of homeostatic disturbance or sensory alterations may occur. the goal of the study is to observe activity, stress and sleep parameters in relation to registered headache attacks. participation in the mbrain-21 study will last maximum 90 days. participants are patients with migraine or cluster heacache recruited within the headache clinic of ghent university hospital. physiological variables such as heart rate, movement and galvanic skin resonse will be measured by the empatica e4 wrist sensor. patient-specific experiences during headache attacks and activities of daily life will be registered with a custom-made headache smartphone applications. contextual data (e.g. smartphone usage or location) can be autonomously collected through smartphone applications.

Eligibility criteria:
inclusion criteria: * adult participants between the age of 18 en 65 years. * diagnosis of migraine without aura (ichd-3 diagnosis 1.1) or migraine with aura (ichd-3 diagnosis 1.2) or chronic migraine (ichd-3 diagnosis 1.3) * headache crystal clear days on minimum 5 days per month on average. * onset of headache syndrome before the age of 50. * attacks of migraine or cluster headache are clearly distinguishable from other types of headache disorders if present. * participant complies with protocol to use smartphone applications on his or her own android-based smartphone (minimum version 8.0) and to provide access to his or her smartphone dataplan. exclusion criteria: -

Keywords: migraine cluster headache smartphone application machine learning wearable sensor
immune response to covid-19 in 300 health care workers with mild symptoms

Conditions: COVID-19; Serology

Summary: three hundred healthcare workers with mild symptoms for covid-19 will be followed during three months. each two weeks, serological tests will be performed. re-infection will be monitored by saliva-swabs.


Eligibility criteria:
inclusion criteria: * hcw previous tested for covid-19 with mild symptoms in jessa ziekenhuis, belgium exclusion criteria: -
clinical investigation of refraction techniques

Conditions: Refractive Error

Summary: prospective, multi-center, non-interventional, randomized, comparative clinical study to identify an optimal refractive technique that provides maximum plus refractive endpoint for best corrected distance visual acuity (bcdva).


Eligibility criteria:
inclusion criteria: 1. participant in pcol-102-ahsf who were bilaterally implanted with tecnis iol, models c1v000, c2v000 or icb00 and have completed and are at least 30 days postoperative from their second eye surgery; 2. at least one implanted eye with clear ocular media; 3. signed informed consent and hipaa authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in australia and new zealand; 4. availability, willingness and sufficient cognitive awareness to comply with examination procedures. exclusion criteria: 1. best-corrected distance visual acuity (bcdva) worse than 0.66 decimal (6/9 or 20/30 snellen); 2. subjects with ongoing adverse events that might impact outcomes during the study visit as determined by the investigator.
efficacy and safety of indacaterol plus tiotropium versus tiotropium alone in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (copd)


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd) (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease \[gold\] guidelines, 2007) and: 1. smoking history of at least 10 pack-years 2. post-bronchodilator forced expiratory volume in 1 second (fev1) ≤ 65% and ≥ 30% of the predicted normal value 3. post-bronchodilator fev1/fvc (force vital capacity) \< 70% exclusion criteria: * patients who have had a copd exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period * patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period * patients with a body mass index less than 15 or more than 40 kg/m\^2 * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: chronic obstructive pulmonary disease copd indacaterol tiotropium bronchodilation
efficacy/safety pilot study to investigate iberogast n's efficacy in mild to moderate colitis ulcerosa patients

Conditions: Colitis, Ulcerative

Summary: the study will investigate efficacy of stw5-ii as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate active ulcerative colitis (uc), i.e. clinical activity index (cai) ≥ 5 up to 10 points (including) * patients in whom the active uc is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before visit 2 * age between 18 to 80 years (including) * uc may reach from left-sided colitis to pancolitis exclusion criteria: * severe forms of uc (cai \> 10) * crohn's disease, infectious colitis or undetermined colitis * steroid dependence and steroid resistance * concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants * antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented * prior medication with biologicals, immune modifiers and immunosuppressants \< 3 month wash-out * total colectomy * known allergies to components of stw5-ii * severe allergic diathesis * topical mesalazine application * known intolerance to azo dyes e110 and e151

Keywords: iberogast n mild to moderate ulcerative colitis add-on therapy efficacy
phase ii exploratory clinical study of kux-1151

Conditions: Hyperuricemia

Summary: the purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of kux-1151 in patients with hyperuricemia including gout.


Eligibility criteria:
inclusion criteria: * japanese hu patients (outpatient) * patients who meet the following criteria concerning serum uric acid levels at the screening \[1) gout: \> 7.0 mg/dl, 2) hu with complications: ≥ 8.0 mg/dl, 3) hu without complications: ≥ 9.0 mg/dl\] exclusion criteria: * patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration

Keywords: hyperuricemia
24-hour intraocular pressure (iop) control with the bimatoprost/timolol fixed combination

Conditions: Glaucoma

Summary: the objective of this crossover, randomized, placebo controlled, double-masked study is to compare the short-term (12 weeks) mean 24-hour iop control and safety of the new fixed combination (bimatoprost/timolol, btfc) given pm with placebo once in the morning, versus btfc given am with placebo once in the evening versus bimatoprost given in the evening in patients with exfoliative glaucoma (xfg).

primary study objectives * to show that the mean 24-hour iop control obtained with btfc (morning or evening) is statistically better to that with bimatoprost monotherapy given once on the evening. * to demonstrate that the fixed combination will provide a significantly better iop control in the morning when dosed in the evening. * to test whether the mean 24-hour iop control obtained with btfc given once in the evening may be statistically better to that with btfc given once in the morning. * to show whether there will be less 24-hour fluctuation of iop with the evening dosing of btfc. study population consecutive newly-diagnosed, or suitably washed-out patients with exfoliative glaucoma (xfg) who exhibit a mean untreated iop greater than 25 mm hg at baseline (10:00).

Eligibility criteria:
inclusion criteria: * the patient is suffering from xfg (if the patient has bilateral xfg, both eyes will be treated, but the worse eye will be selected for the statistical analysis) * patient is older than 39 years and younger than 85 years * patient is able and willing to participate in the study for the whole duration of the follow up. will sign the consent form. * at screening the untreated iop at 10:00 (± 1 hr) is greater than 25 mm hg and lower than 40 mm hg * after bimatoprost run-in therapy the treated iop at 10:00 (± 1 hr) is greater than 19 mm hg

Keywords: 24-hour iop control
n-3 polyunsaturated fatty acids enriched chicken meet and cardiovascular function

Conditions: n-3 Polyunsaturated Fatty Acids

Summary: evidence from multiple experimental, epidemiological, and clinical studies indicate that n-3 polyunsaturated fatty acids (n-3 pufas) may exert their cardiovascular (cv) protective effect, at least in part, by improving vascular endothelium-dependent function. previously, the investigators demonstrated the significant beneficiary effect of consumption of n-3 pufa-enriched hen eggs on microvascular endothelium-dependent reactivity, even in young healthy individuals. the hypothesis of this research is that the consumption of n-3 pufas in the form of functionally enriched chicken meet has a beneficial effect on vascular reactivity measured in different vascular beds, and the lipid profile with a positive effect on the reduction of oxidative stress and inflammatory response in healthy sedentary individuals. the main goal of this study is to investigate the influence of n-3 pufas functionally enriched chicken meet on vascular and endothelial function in a population of healthy young subjects and active athletes.


Eligibility criteria:
inclusion criteria: * young healthy sedentary individuals - did not perform regular physical activities for at least 12 months before conducting the study * young healthy active athletes - have a minimum of 5 training sessions per week (mainly endurance training) for at least 12 months prior to conducting the study exclusion criteria: * smoking * hypertension * coronary disease * diabetes * hyperlipidemia * kidney damage * cerebrovascular and peripheral artery diseases * and any other disease that could have an impact on vascular and endothelial function

Keywords: n-3 polyunsaturated fatty acids vascular function endothelium oxidative stress inflammation microcircularion macrocirculation